Azra Rajwani

Big changes in ISO 14971:2019

changes in ISO 14971:2019Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.

Continue reading »

Kristofor Dolberg

Advantages and Disadvantages of Designing a Custom PCB 

Designing a Custom PCB When designing an electrical or electronic system, product designers may find themselves asking “Should we be spinning a custom PCB (Printed Circuit Board), or hand-wiring on a perfboard or breadboard?” This article discusses some of the advantages and disadvantages of Designing a Custom PCB identified during a group discussion of StarFish Medical electronic engineers.

Continue reading »

Zach Mears

How to get the most from your FDM 3D printer

How to get the most from your FDM 3D printer

Three test prints used to test the dimensional accuracy of an FDM 3D printer.

Fused Deposition Modelling (FDM) desktop 3D printers have become a huge part of prototyping and testing. Knowing how to get the most out of your 3D printer is increasingly important when designing parts. There are countless factors that influence the quality of your final printed parts, such as print temperature, layer height, and print speed. Here are a few key things to keep in mind when designing parts for an FDM 3D printer.

Continue reading »

Aaron Philippsen

How to construct a custom differential screw

Custom differential screwUnderstanding a differential screw and how to construct one

I recently had to construct a custom differential screw when designing a precision test fixture for one of our medical device projects.  We used it to locate a test piece within +/-0.03mm. This motion required minimal force, and each part required a set of specific locating features. There are several options available to produce this motion, but due to the configuration and location features of our test piece, we pursued a custom solution using a differential screw.

Continue reading »

Astero StarFish

Our 10 most read medical device commercialization blogs of 2019

authors of most read medical device commercialization Two new medical device commercialization blogs and authors joined our 2019 “most read” list.  Regulatory and electrical engineering articles tied for most popular topic (4 each), followed by biotech and supply chain. Many thanks to our employee authors past and present for their contributions to medical device excellence.

Continue reading »

Laura Gouzecky

How ERP Benefits Medical Device Commercialization

How ERP Benefits Medical Device Commercialization
I’m often asked how ERP benefits medical device commercialization. Enterprise resource planning (ERP) is a very powerful tool that helps many companies succeed.  The medical device industry faces unique challenges from FDA and CFR requirements, regulations, and standards. These challenges mean that ERP can aid medical device commercialization even more than other industries and products.

Continue reading »

Astero StarFish

Top 10 medical device commercialization lessons and tips

medical device commercialization lessons We asked our development and commercialization experts to share their top medical device commercialization lessons and tips based upon actual medical device development and commercialization experiences.  Their recommendations cover projects from working at StarFish as well as other medical device organizations.  Many include links to blogs with additional information. Here are 10 ideas to increase your medical device commercialization success in 2020:

Continue reading »

Nick Allan

How to research the Infectious Disease Diagnostics market potential

Infectious Disease Diagnostics market potentialThe internet is full of great research data. This blog shows how to research four questions one should address when considering Infectious Disease Diagnostics market potential by using public information. I explain how publicly posted research and reports can help analyse and build answers for activities like developing a new PoC Assay.

Continue reading »

Lindsey

5 Tricks that reduce low volume supplier lead times

reduce low volume lead timesNegotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill.  Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders.
The pre-planned anticipated lead time in your ERP (Enterprise Resource Planning) system must be correct with no room for error. A caveat being early delivery. This is usually welcomed without penalty to supply chain.

Continue reading »

Kathryne Young

Tackling Supply Chain Quality Challenges in low volume manufacturing

tackling supply chain quality challenges in low volume manufacturing
Supply chain quality challenges in low volume manufacturing for medical device manufacturers include analysis of the data measuring supplier performance in relation to product risk. Under ISO 13485:2016, section 7.4, purchasing has a higher profile and more stringent requirements for documented purchasing process and supplier management.

Continue reading »

Vanessa Del Castillo Faria

How to extract good value from your medical device supply chain

extract good value from your medical device supply chain
Manufacturing low volume, high complex medical device products requires sourcing highly customized and expensive parts. This makes it hard to extract good value from your medical device supply chain.
While high-volume production enables economies of scale, low volume custom-made production involves fewer parts to absorb product development, tooling and production equipment costs.

Continue reading »

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.